A non-interventional, observational study of a fixed combination of pepsin and amino acid hydrochloride in patients with functional dyspepsia

BMC Gastroenterol. 2017 Nov 25;17(1):123. doi: 10.1186/s12876-017-0675-9.


Background: Functional dyspepsia (FD) is a gastrointestinal disorder characterized by recurrent and diverse symptoms and pathophysiology that remains unexplained following routine clinical investigation. Enzynorm®f is a pharmaceutical preparation comprising fixed amounts of pepsin of biological origin and organically bound acid in the form of amino acid hydrochloride. It is traditionally used as a mild agent to support gastric function and to stimulate the stomach's proteolytic activities in FD.

Methods: In a non-interventional, observational, post-marketing surveillance study, patients with an established diagnosis of FD were treated with a fixed combination of pepsin and amino acid hydrochloride taken as tablets three times daily for 6 weeks. The primary objective of this study was to assess the change in symptoms using the validated Gastrointestinal Symptom Score (GIS©). Secondary objectives included patients' assessment of their gastrointestinal symptoms as well as treatment safety and tolerability.

Results: A total of 97 patients (mean age 58.4 ± 13.9 years; 63.2% females) were included in the study, with 72 data having GIS© score data at baseline and at 6 weeks, and 34 also at 3 weeks. The overall GIS© sum score decreased by 4.1 (p < 0.0001) from 11.6 (±4.8) at baseline to 7.4 (± 4.6) reflecting an improvement of clinical symptomatology after 6 weeks of treatment. In a subgroup of 70 patients who had FD meeting the Rome III criteria a GIS© score reduction of ≥50% was observed after 3 weeks treatment in 24% and in 30.8% after 6 weeks. Adverse events were mostly gastrointestinal in nature and consistent with the underlying disease; no unexpected adverse reactions were reported. Twenty-seven patients discontinued the study, mostly because of gastrointestinal symptoms.

Conclusion: The results of this study support the efficacy of a fixed combination of pepsin and amino acid hydrochloride for the treatment of patients with FD and also suggest good to moderate treatment tolerability. These findings should be further explored in a randomised, placebo-controlled clinical trial.

Clinical trial registration: This study has been retrospectively registered in the ClinicalTrials.gov registry, trial identifier NCT03076411 .

Keywords: Enzyme therapy; Functional dyspepsia; Natural remedy; Non-interventional trial; Observational trial; Pepsin.

Publication types

  • Observational Study

MeSH terms

  • Amino Acids / adverse effects
  • Amino Acids / therapeutic use*
  • Drug Administration Schedule
  • Drug Combinations
  • Dyspepsia / drug therapy*
  • Female
  • Gastrointestinal Agents / adverse effects
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Patient Outcome Assessment
  • Pepsin A / adverse effects
  • Pepsin A / therapeutic use*
  • Product Surveillance, Postmarketing
  • Treatment Outcome


  • Amino Acids
  • Drug Combinations
  • Gastrointestinal Agents
  • Pepsin A

Associated data

  • ClinicalTrials.gov/NCT03076411